{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T20:50:15Z","timestamp":1788814215499,"version":"build-2803163510"},"reference-count":78,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2022,10,22]],"date-time":"2022-10-22T00:00:00Z","timestamp":1666396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2022,10,22]],"date-time":"2022-10-22T00:00:00Z","timestamp":1666396800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:p>Chronic hepatitis D infection results in the most severe form of chronic viral hepatitis but currently lacks effective treatment options. Therapy with pegylated interferon alpha is recommended for finite treatment duration by major liver societies. Still, it is plagued by low rates of sustained virologic response (SVR) and frequent relapses even if SVR is achieved. Recently, a wave of investigational therapies has come under evaluation, including bulevirtide, lonafarnib, pegylated interferon lambda, and REP\u20102139 creating excitement with this viral infection. However, there has been significant variability in the endpoints used to evaluate these therapeutics. One of the recently introduced endpoints is characterized by a decline in HDV RNA by 2 logs, with or without achieving an undetectable serum hepatitis D virus (HDV) RNA, as a marker of virologic response. Furthermore, this measure has been combined with alanine aminotransferase normalization, also known as a biochemical response, to formulate the primary endpoint of several late\u2010stage studies. Per recent guidance by the US Food and Drug Administration, these should be surrogate endpoints that will ultimately portend long\u2010term clinical benefits. These clinical benefits may include reducing the risk of progression to cirrhosis, hepatic decompensation, hepatocellular carcinoma, liver transplantation, and mortality. However, the optimal way to measure success in HDV clinical trials remains unknown and will continue to evolve.<\/jats:p>","DOI":"10.1002\/hep.32732","type":"journal-article","created":{"date-parts":[[2022,8,15]],"date-time":"2022-08-15T08:54:40Z","timestamp":1660553680000},"page":"2147-2157","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":8,"title":["Clinical trials in hepatitis D virus: Measuring success"],"prefix":"10.1097","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7750-240X","authenticated-orcid":false,"given":"Ben L.","family":"Da","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2022,10,22]]},"reference":[{"key":"hep32732-bib-0001-20250824","doi-asserted-by":"crossref","first-page":"1677","DOI":"10.1093\/infdis\/jiz633","article-title":"Estimating the global prevalence, disease progression, and clinical outcome of hepatitis delta virus infection","volume":"221","year":"2020","journal-title":"J Infect Dis"},{"key":"hep32732-bib-0002-20250824","doi-asserted-by":"crossref","first-page":"523","DOI":"10.1016\/j.jhep.2020.04.008","article-title":"The global prevalence of hepatitis D virus infection: systematic review and meta\u2010analysis","volume":"73","year":"2020","journal-title":"J Hepatol"},{"key":"hep32732-bib-0003-20250824","doi-asserted-by":"crossref","first-page":"1046","DOI":"10.1016\/j.jhep.2020.06.038","article-title":"Origin, HDV genotype and persistent viremia determine outcome and treatment response in patients with chronic hepatitis delta","volume":"73","year":"2020","journal-title":"J Hepatol"},{"key":"hep32732-bib-0004-20250824","doi-asserted-by":"crossref","first-page":"931","DOI":"10.1093\/infdis\/155.5.931","article-title":"Influence of hepatitis delta virus infection on progression to cirrhosis in chronic hepatitis type B","volume":"155","year":"1987","journal-title":"J Infect Dis"},{"key":"hep32732-bib-0005-20250824","doi-asserted-by":"crossref","first-page":"433","DOI":"10.1111\/j.1440-1746.1993.tb01543.x","article-title":"Risk of liver cirrhosis and hepatocellular carcinoma in subjects with hepatitis B and delta virus infection: a study from Kure, Japan","volume":"8","year":"1993","journal-title":"J Gastroenterol Hepatol"},{"key":"hep32732-bib-0006-20250824","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.ijid.2018.07.005","article-title":"Epidemiology and clinical outcomes of hepatitis delta (D) virus infection in Queensland, Australia","volume":"74","year":"2018","journal-title":"Int J Infect Dis"},{"key":"hep32732-bib-0007-20250824","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1016\/j.jhep.2015.04.025","article-title":"Delta hepatitis within the Veterans Affairs medical system in the United States: prevalence, risk factors, and outcomes","volume":"63","year":"2015","journal-title":"J Hepatol"},{"key":"hep32732-bib-0008-20250824","doi-asserted-by":"crossref","first-page":"420","DOI":"10.1136\/gut.46.3.420","article-title":"Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type B. 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